BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT ACET WINDOW TRIAL 56MM

    MDR report key: 2253069 · Received August 31, 2011

    Report

    Report Number
    2249697-2011-01293
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED, "THE SHELL TRIAL WAS INSERTED AND THE THREADS ARE STRIPPED. THEREFORE, THE TRIAL WAS DIFFICULT TO REMOVE AND PLIERS WERE NEEDED TO REMOVE THE TRIAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT ACET WINDOW TRIAL 56MM INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA 30683401

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention